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Clinical Trials/NCT05076539
NCT05076539
Unknown
Not Applicable

A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker

Singapore General Hospital1 site in 1 country50 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Singapore General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Oxford Knee
Last Updated
4 years ago

Overview

Brief Summary

This study aims to evaluate the patients' mobility and quality of life prior to their total knee replacement surgery and their progress pre-operatively and 6 months post-operatively using the smart activity tracker. We hypothesize that mobility limitation presents a strong correlation with reduced quality of life.

Detailed Description

The present study is to determine the effect of TKA based on their mobility and QOL pre and post surgery. The GPS and accelerometry-based tracker will be able to provide quantitative-based outcomes to indicate the physical activity of patients after TKR remains at or above pre-surgical levels. A total of 50 participants are to be enrolled in this cross-sectional study. Patients who will be required to undergo unilateral total knee replacement will be recruited when fulfilling the respective inclusion and exclusion criteria. The patients will undergo the standard consultations and rehabilitation pre - and post operative care, no changes to the treatment itself will be made. After recruitment and counseling by the surgeon for TKR, the patients will have pre-operative baseline clinical scores taken prior to surgery. They will subsequently have their TKR surgery. Post-operatively, they will be followed up prospectively at the clinics as well as Orthopaedics Diagnostic Centre. Their outcome will be evaluated using validated scoring system, Oxford Knee Score, SF-36, Knee Society Clinical Rating System, satisfaction questionnaire, as well as be provided with a GPS-activity tracker. 50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery). The de-identified raw data gathered from the Garmin tracker will be collected by Curtin University for their analysis. The patients will undergo the standard consultations and rehabilitation pre - and postoperative care, no changes to the treatment itself will be made. Standard consultations/review by orthopaedic specialist * Pre-surgery * 6 months post surgery Standard Orthopaedic Diagnostic Center (ODC) data collection timepoints * Pre-surgrey * 6 months Standard rehabilitation care * Upon discharge * 2 - 3 weeks post discharge in outpatient services (OPS) On top of the standard consultations and rehabilitation pre - and postoperative care, the patients will be monitored on their normal lifestyle at home using a tracker worn on their wrists for 1 week, pre-operatively and 6 months post surgery.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
January 30, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who are referred by the Orthopaedic surgeon and are diagnosed with Knee Osteoarthritis, and consented to unilateral total knee replacement.
  • Able to ambulate with or without walking aid.
  • Ability to provide informed consent.

Exclusion Criteria

  • Patients who have severe bilateral Knee Osteoarthritis, affecting their ability to walk and only one will be operated on.
  • Patients with pre-existing cognitive issues, such as dementia.
  • Patients planning for another surgery within 6 months after their TKR.
  • Patients with existing co-morbidities that limit their walking ability, such as severe respiratory distress syndromes.

Outcomes

Primary Outcomes

Oxford Knee

Time Frame: 6 months post surgery

Using the Oxford Knee questionnaire to get the oxford knee score

Discharge Destination

Time Frame: up to 6 months post surgery

Where the patient will be going to after discharge from SGH

SF 36 Health survey

Time Frame: 6 months post surgery

SF36 questionnaires to get SF-36 scores

Type of walking aids used

Time Frame: up to 6 months post surgery

The type of walking aids required, namely, walking frame, broad- and narrow-based quadstick, or walking stick (in descending order of base of support provided)

Data Collected from Garmin GPS-activity tracker

Time Frame: 6 months post surgery for 1 week

1. Latitude and longitudinal location coordinates to determine an individual's activity space 2. Distance travelled 3. Walking speed 4. Heart rate 5. Calories burned 6. Energy expenditure 7. Steps count 8. Physical activity

Knee Society Clinical Rating system

Time Frame: 6 months post surgery

Measuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)

Length of stay

Time Frame: up to 6 months post surgery

the number of nights spend in the hospital from the day of surgery

Knee range-of-motion

Time Frame: up to 6 months post surgery

measure knee ROM

Ability to perform a straight leg raise

Time Frame: up to 6 months post surgery

If patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer

Expectation met for surgery

Time Frame: 6 months post surgery

Patient satisfaction form

Overall result of surgery

Time Frame: 6 months post surgery

Subject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)

Premorbid history

Time Frame: up to 6 months post surgery

Patients reported ambulation status before surgery, including the use of walking aids and assistance level required

Early ambulation rate

Time Frame: up to 6 months post surgery

Percentage of patients who start walking postoperative day (POD) 1

Study Sites (1)

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